Transcription of GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …
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GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …
Working document September 2018. Draft document for comments 1. 2 GUIDELINES ON VALIDATION APPENDIX 4. 3 ANALYTICAL METHOD VALIDATION . 4. 5 (September 2018). 6. 7 DRAFT FOR COMMENTS. 8. 9. Please forward any comments you may have on the attached text to Dr Sabine Kopp, Group Lead, 10. 11. Medicines Quality Assurance, Technologies, Standards and Norms with a copy to Mrs Xenia Finnerty by 15 November 2018. 12. 13. Medicines Quality Assurance working documents will only be sent out electronically and will 14. 15. also be placed on the Medicines website for comments under Current projects . If you have 16. not already received our draft working documents, please send your email address (to 17.)
The tests to be performed 136 should be described in the documentation on standard test methods. 137 2.2 138 Specifications and standard test methods in pharmacopoeias (“pharmacopoeial 139 methods”), or suitably developed specifications or test methods (“non-pharmacopoeial methods”)
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